Episode Details

Audit trail review can involve far more than checking whether a system records changes. In this QCast episode, co-hosts Jullia and Tom discuss how trial teams can decide what needs review, where risk should shape scope and timing, and why unusual activity needs context before it becomes a finding.

Key Takeaways

• Audit trail review should focus on relevant risks and questions rather than attempting to review every available event.
• Trial-level and system-level review can have different purposes and owners, so scope and responsibilities need to be clear.
• A flagged event still needs interpretation against the clinical data and study context before deciding whether action is required.

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📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
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About Quanticate

Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in:

• Clinical Data Capture & Management
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